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Our Services

At IUVO Consulting, LLC, we specialize in guiding companies through the complexities of U.S. FDA regulatory compliance. Our flat-rate, project-based approach ensures that you get your product on the market easily and quickly – and with no surprises.

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Explore Our Specialized Services

Regulatory Compliance Submissions

Navigating FDA regulations for drugs, foods, cosmetics, and medical devices can be challenging. We provide expert assistance to streamline your submissions.

Drugs

Annual registration, product listing, labeling reviews, and U.S. Agent services.

Medical Devices

 510(k) and 513(g) submissions, pre-submission meetings, De Novo requests, establishment registration, product listing, and labeling reviews.

Foods and Dietary Supplements

Facility registration, prior notice submissions, and labeling compliance.

Cosmetics

Facility Registration, product listing, ingredient reviews, and labeling guidance.

IUVO Consulting

Regulatory Strategy Development

We collaborate with your team to develop effective regulatory strategies aligned with your product pipeline and business objectives. Our goal is to enhance your market share in the U.S. by providing:

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Comprehensive evaluations of your current regulatory approach.

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Customized compliance roadmaps to meet FDA requirements.

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Ongoing support to navigate regulatory challenges and avoid common pitfalls.

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Get Expert Guidance on Your Regulatory Strategy

Explore how we can help you design and execute your company’s regulatory strategy.

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About IUVO Consulting

IUVO Consulting, LLC provides expert guidance to help medical device, drug, food and cosmetic companies to achieve and maintain FDA compliance.

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